Tukol Honey Nighttime Cold and Flu

Manufacturer
Genomma Lab USA
Effective date
2024-10-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:28:05

Label at a glance#

ProductTukol Honey Nighttime Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections

Indications and uses

Temporarily relieves these common cold and flu symptoms: sore throat headache minor aches and pain runny nose and sneezing cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage and administration

do not take more than directed do not take more than 4 doses in any 24 hours this adult strength product is not intended for use in children under 12 years of age measure only with dosing cup provided keep dosing cup with product mL = mililiter TBSP = tablespoon dose as follows age dose adults and children 12 years of age and over 30 mL (2 Tablespoons) every 6 hours Children under 12 years of age do not use when u...

Storage and handling

Each 30 mL contains: sodium  18 mg store between 15-30 o C (59-86 o F) do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (in each 30 mL)Purpose
Acetaminophen 650 mgPain reliever/Fever reducer
Dextromethorphan HBr 30 mgCough suppressant
Doxylamine Succinate 12.5 mgAntihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these common cold and flu symptoms:

  • sore throat
  • headache
  • minor aches and pain
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

The product contains Acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses (30 mL) in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions. Symptoms may include

  • skin reddening
  • blisters
  • rash.

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • to make a child sleepy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma chronic bronchitis or emphysema
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

  • if you are taking sedatives or tranquillizers
  • if you are taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose may cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • do not take more than 4 doses in any 24 hours
  • this adult strength product is not intended for use in children under 12 years of age
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = mililiter
  • TBSP = tablespoon
  • dose as follows
agedose
adults and children 12 years of age and over30 mL (2 Tablespoons) every 6 hours
Children under 12 years of agedo not use

when using day time and night time prodcuts, carefully read each label to ensure correct dosing.

Other information

STORAGE AND HANDLING SECTION

  • Each 30 mL contains: sodium  18 mg
  • store between 15-30 oC (59-86 oF)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, FD&C Yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-877-994-3666

Monday to Friday 8 am to 6 pm, Central Time

SPL UNCLASSIFIED SECTION

Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77098

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 118 ml Bottle CartonPRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

Night Time

Tukol ®
HONEY MULTISYMPTOM

COLD & FLU

Acetaminophen/ Dextromethorphan HBr /
Doxylamine succinate

Ages
12+

NATURAL

HONEY
FLAVOR

Relieves:

  • HEADACHE, SORE THROAT, FEVER
  • MINOR ACHES AND PAINS
  • SNEEZING, RUNNY NOSE
  • COUGH

4 FL OZ (118 ml)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN9
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD9
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY9
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY9
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-303-04Tukol Honey Nighttime Cold and Flu1 in 1 CARTONSYRUP19
50066-303-04Tukol Honey Nighttime Cold and Flu118 mL in 1 BOTTLE, PLASTICSYRUP1189

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-303TUKOL HONEY NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) SYRUP [GENOMMA LAB USA]9Current NDC, Legacy NDC, 2 package rows20241023_bf25f38e-3549-4f78-be90-46605b5f2c11.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-30350066-303-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tukol Honey Daytime and Nighttime Value PackACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAbccc11d2-d227-4cbb-b0fc-ac6abb6dce572024-10-22WarningsExact identifier
ndc (package): 50066-303-04
ndc11 (package): 50066030304
Tukol Honey Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAbf25f38e-3549-4f78-be90-46605b5f2c112024-10-21WarningsExact identifier
ndc (package): 50066-303-04
ndc (product): 50066-303
ndc11 (package): 50066030304
spl id: 24fec102-30d8-373f-e063-6394a90ac8ab
spl set id: bf25f38e-3549-4f78-be90-46605b5f2c11

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.